“One could not always put safety up front as the prime goal. Do that, and who would ever achieve anything of note?” Jack McDevitt

Introduction

The word “safety” is mentioned 46 times in the current guidelines:

Word Frequency Rank Adjusted Rank trial 437 1 1 subject 256 2 2 sponsor 210 3 3 clinical 207 4 4 investigator 155 5 5 product 149 6 6 data 120 7 7 investigational 113 9 9 protocol 103 11 10 regulatory 103 12 11 monitor 97 14 12
IRB/IEC 88 19 14 inform 73 26 15 consent 68 30 16 procedure 61 34 18 investigator/institution 58 35 19 record 58 36 20 appropriate 52 37 21 requirement 50 38 22 review 49 39 23 safety 46 41 24 quality 43 44 25 adverse 38 48 27 authority 35 50 29

Interestingly, as can be seen in the above abbreviated table, …show more content…
Why is the CRA role so vital?

This isn’t just about checking for unreported SAEs, verifying SAE reports and chasing investigators for causalities. We need to consider safety from draft protocol through to Clinical Study Report; if you analyse where the word safety appears in the guidelines you notice that it isn’t just in the context of safety reporting, but appears throughout the guidelines (e.g. It appears in: clinical trial definition; EC/IRB definition; IC of trial subjects; quality management; record keeping & data handling; Information on IP).

Returning to my earlier question, why is the CRA role so vital: the CRA is the eyes and ears of the Sponsor. It’s true that Sponsor companies use an ever-increasing amount of technology (e.g. RBM) to remotely monitor all aspects of a trial. But, trials involve patients, nurses, doctors, administrators, all of whom are individual and fallible. Further, the technology is reliant on the amount and quality of the data entered – the CRA is the one who verifies that what the technology is analysing and processing is what is really happening, what the patients are really …show more content…
For example, you can see that the IP has been received in good condition, that it has been prepared for dispensing and dispensed per protocol, given to the patient per protocol and any returns have been accounted for; what was the pharmacists experience of preparation? How long did it take to prepare and dispense? Was is it easy to administer? What do the patients think? If it was uncomfortable to administer, is this captured in the way the patient wants it recorded (is the PRO relevant)? Was the patient’s experience in line with what they’d understood from the PIS and consented to? It is rare that any of this data is captured as part of a trial but all could have a significant impact on the safe conduct of the